ABSTRACT
Objectives: the COVID pandemic has accelerated the uptake of digital health interventions (DHIs) in healthcare systems. The aim of this rapid review is to provide an overview about the evidence frameworks required by payers when assessing DHIs. Methods: we reviewed recent literature and the websites of the leading payer and HTA bodies (Australia, Canada, Western Europe) for evidence frameworks which have been developed for the evaluation of DHIs. We sought whether and how the following evidence framework domains were covered: health problem and comparator, safety, clinical effectiveness as well as patient and social, economic, legal, ethical, organizational and technical / stability aspects, usability, data security and interoperability. Results: as of September 2021, we identified 6 evidence frameworks specific to reimbursement decisions concerning DHIs from Australia (Medical Services Advisory Committee, MSAC), Belgium (National Institute for Health and Disability Insurance, RIZIV), Germany (Federal Institute for Drugs and Medical Devices / Directory of Reimbursable Digital Health Applications, BfARM / DiGa), Finland (Finnish Coordination Centre for Health Technology Assessment, FinCCHTA), France (French National Authority for Health,HAS) and the United Kingdom (National Institute for Health and Care Excellence, NICE). All frameworks specified requirements concerning the health problem and comparator, safety, clinical effectiveness as well as patient and social aspects. Four-four frameworks covered legal and ethical aspects (Australia, Belgium, Germany, United Kingdom) as well as organizational aspects, data security and interoperability (Australia, Belgium, Germany, Finland) and technical aspects / stability (Australia, Germany, Finland, France). Usability was covered by only three frameworks (Australia, Germany, Finland). Conclusions: The evidence frameworks for DHIs require a wider perspective than is often applied to pharmaceuticals. However, they require additional refinement to ensure that the level of evidence is commensurate with the technology being assessed and that relevant stakeholders are included to assess more holistically produced outcomes.
ABSTRACT
Objectives: COVID-19 has accelerated the use of digital health, however, there is no universally accepted definition. The objective of this scoping review was to provide an overview of definitions in the literature including the context in which it exists e.g. public health organization, supplier organization, etc. to derive those which are aligned with the ISPOR mission of outcomes research. Methods: A literature search was undertaken for the past 5 years (2015-2020) on the major specific terms used in digital health (n=38) where these exist with synonyms of definition as a key term. Databases searched included Embase, PubMed/Medline, Cochrane Library and EconLit. A team of 2 volunteers independently reviewed each abstract to identify those which were likely to contain a definition or taxonomy and then reconciled any misalignment between the authors or referred the abstract to a third-party reviewer. Independent review by 2 volunteers was also employed to extract the relevant parameters in a recording spreadsheet from the full paper review. Results: From 2966 hits in the four different databases (Embase: n=2263;PubMed: n=657, Cochrane n=35, EconLit: n=11), the scoping review identified 2,610 original abstracts. Fifteen teams of two independent volunteers undertook the review of the abstracts. The agreement between the initial assessments of rater pairs was between 97.1% and 36.2%. Cohen’s kappa ranged from 0.91 to 0.11. A third reviewer reconciled disagreement in 73 (2.8%) citations. The number of abstracts taken through to the full paper review was 545 (20.9%). Conclusions: This timely work indicates that definitions included in the literature cover several terms which can be grouped under different applications of digital health. An overview of the different terms and their context to identify options which align with the ISPOR Mission will be presented.